FDA Accepts Unicycive’s Oxylanthanum Carbonate NDA Resubmission
Unicycive Therapeutics said the FDA accepted its resubmitted new drug application for oxylanthanum carbonate and set a PDUFA date of March 25, 2027.
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Unicycive said the FDA accepted its resubmitted NDA for oxylanthanum carbonate and set a Class II review with a PDUFA target action date of Mar 25, 2027. The filing includes CMC data from a new third-party manufacturer.Material DetailsContext by AI AnalystThis is a regulatory reset after prior CRLs…
MOUNTAIN VIEW, Calif., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) NASDAQ:UNCY, a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accept…